Class I - Dangerous
The product does not meet certain internal strength testing specifications.
🔪
Surgical Instruments
🏥 Medical Devices • 6,839 recalls
NEONATAL PROCEDURE TRAY PICC CATHETERS CVI4535
Centurion Medical Products
Class I - Dangerous
Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.
Instruments were developed without adequate consideration given to the need for a new regulatory filing. This event was reported to FDA as part of Stryker's retrospective review of K2M product field actions; recall actions were completed in 2017.
Class I - Dangerous
Mislabeled needle lengths
Centurion CIRCLAMP W/1.3 CM BELL-single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 330CR
Centurion Medical Products
Class I - Dangerous
A mismatch between the angle of the hole in the base and the angle of the bell, which may cause the clamp to remove foreskin without the use of a scalpel.
Centurion CIRCLAMP W/1.1CM BELL - single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 310CR
Centurion Medical Products
Class I - Dangerous
A mismatch between the angle of the hole in the base and the angle of the bell, which may cause the clamp to remove foreskin without the use of a scalpel.
Class I - Dangerous
The product does not meet certain internal strength testing specifications.
Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771
Stryker Neurovascular
Class I - Dangerous
Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging
Class I - Dangerous
Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (GA) values in a reversed manner.
CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement Connector for needleless access to the IV line and/or IV catheter during IV therapy Cat. No. MP1000-C
Becton Dickinson & Company
Class I - Dangerous
After disconnection of a luer, the valve of the connector remains recessed; not fully closing, either temporarily or permanently. The risks of blood loss and air embolism exist if the valve remains permanently open and goes undetected, especially in the neonate population.
SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.0, .070", REF SA6AL10. for cardiovascular use
Medtronic Vascular
Class I - Dangerous
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.0 SH, .070", REF SA6JL30SH. for cardiovascular use
Medtronic Vascular
Class I - Dangerous
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350
Inter-Med
Class I - Dangerous
The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.
SHERPA NX ACTIVE GUIDING CATHETER, 6F, 3DRC 100CM .070", REF SA63DRC. for cardiovascular use
Medtronic Vascular
Class I - Dangerous
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD RIGHT SHORT TIP, .070", REF SA6ERADRST. for cardiovascular use
Medtronic Vascular
Class I - Dangerous
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
SHERPA NX ACTIVE GUIDING CATHETER, 6F SL4.5, .070", REF SA6SL45. for cardiovascular use
Medtronic Vascular
Class I - Dangerous
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.0, .070", REF SA6AL20. for cardiovascular use
Medtronic Vascular
Class I - Dangerous
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB 90CM, .070", REF SA6LCBD. for cardiovascular use
Medtronic Vascular
Class I - Dangerous
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
SHERPA NX ACTIVE GUIDING CATHETER, 6F 110CM AL20, REF SA6AL20A. for cardiovascular use
Medtronic Vascular
Class I - Dangerous
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
SHERPA NX ACTIVE GUIDING CATHETER, 6F SL5.0, .070", REF SA6SL50. for cardiovascular use
Medtronic Vascular
Class I - Dangerous
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.